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FDA 510(k)

MycoMEIA Aspergillus Assay

N.º K: K243496 · 2025-08-01

SolicitantePearl Diagnostics, Inc.
Fecha de decisión2025-08-01
Código de productoNOM
Comité asesorMI
DecisiónSubstantially Equivalent

Resumen del dispositivo

MycoMEIA Aspergillus Assay is the device name listed in this FDA 510(k) record. The listed applicant is Pearl Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K243496. The device is classified under product code NOM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MycoMEIA Aspergillus Assay?

MycoMEIA Aspergillus Assay is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Pearl Diagnostics, Inc.. The 510(k) number is K243496.

When did MycoMEIA Aspergillus Assay receive FDA 510(k) clearance?

MycoMEIA Aspergillus Assay received FDA 510(k) clearance on 2025-08-01, under 510(k) number K243496.

Who is the listed applicant for MycoMEIA Aspergillus Assay?

The FDA 510(k) record lists Pearl Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MycoMEIA Aspergillus Assay?

The FDA product code for MycoMEIA Aspergillus Assay is NOM.

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Fuente oficial

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